Intervertebral spacer with chamfered edges

ABSTRACT

Intervertebral implants, assemblies, and methods thereof. An intervertebral implant includes opposing chamfered edges to reduce a diagonal distance between the edges. The reduced diagonal distance minimizes distraction of an intervertebral disc space during insertion of the implant. A tool for insertion and rotation of the implant is also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/193,149, filed Jun. 27, 2016, which is incorporated byreference herein in its entirety for all purposes.

FIELD OF THE INVENTION

The present invention relates to a spinal implant and, morespecifically, to a spinal implant with chamfered edges that can beinserted into a disc space and rotated in situ, reducingover-distraction of the disc space.

BACKGROUND

Implants can be inserted to perform Posterior Lumbar Interbody Fusion(“PLIF”) and/or Transforaminal Lumbar Interbody Fusion (“TLIF”) of aspine by inserting the implant on its side and rotating the implant insitu once the implant is located between target vertebrae. A problemassociated with this technique is that the diagonal distance betweenopposing corners of the implant is significantly greater than the heightof the implant, resulting in over-distraction of the disc space in whichthe implant is inserted as the implant is being rotated to its finalorientation. Associated with this over-distraction is also the potentialfor scraping the endplates of either or both of the target vertebraeduring the rotation process.

Accordingly, there exists a need for a rotatable implant that reducesover-distraction of the disc space into which the implant is insertedduring rotation from an insertion position to a final position.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

According to one embodiment, an implant assembly may include a spinalimplant configured to perform TLIF or PLIF procedures, for example. Theassembly may also include a specially designed insertion tool for theinsertion and rotation of the implant in situ after insertion of theimplant into a disc space.

In one embodiment, the implant is a spacer that includes an elongatebody having a central longitudinal axis extending through the body, ananterior portion having an anterior end tapering toward the longitudinalaxis, and a posterior portion, distal from the anterior portion. Asuperior surface extends between the tapered end and the posterior end.A corresponding inferior surface also extends between the anterior endand the posterior end. A first sidewall extends between the superiorsurface and the inferior surface on a first side of the longitudinalaxis and a second sidewall extending between the superior surface andthe inferior surface on a second side of the longitudinal axis. Anintersection of the first sidewall and the superior surface comprises afirst chamfered edge and an intersection of the second sidewall and theinferior surface comprises a second chamfered edge.

In an alternative embodiment, the implant is a spacer that includes anelongate body having a central longitudinal axis extending through thebody, an anterior portion having an anterior end, and a posteriorportion, distal from the anterior portion. A superior surface extendsbetween the anterior end and the posterior end and an inferior surfaceextends between the anterior end and the posterior end. A first sidewallextends between the superior surface and the inferior surface on a firstside of the longitudinal axis and a second sidewall extends between thesuperior surface and the inferior surface on a second side of thelongitudinal axis. A first diagonal distance between an intersection ofthe first sidewall and the superior surface an intersection of thesecond sidewall and the inferior surface is less than a second diagonaldistance between an intersection of the first sidewall and the inferiorsurface and an intersection of the second sidewall and the superiorsurface.

In still another alternative embodiment, an implant assembly includesthe spacer described above and an insertion tool. The insertion tool isremovably attachable to the implant and is adapted to insert the implantbetween adjacent discs. The insertion tool includes a handle and agripper extending distally from the handle. The gripper has a first forkand a second fork extending generally parallel to the first fork. A gapis provided between the first fork and the second fork. The gap is sizedto allow the first fork to be inserted along a longitudinal indentationin the first wall and to allow the second fork to be inserted along alongitudinal indention in the second sidewall.

According to another embodiment, a system comprises an implant and aninsertion tool. The implant having an elongate body having a centrallongitudinal axis extending through the body; an anterior portion and aposterior portion, the posterior portion having an internally threadedopening; a superior surface extending between the anterior portion andthe posterior portion; an inferior surface extending between theanterior portion and the posterior portion; a first sidewall extendingbetween the superior surface and the inferior surface on a first side ofthe longitudinal axis; and a second sidewall extending between thesuperior surface and the inferior surface on a second side of thelongitudinal axis, the first sidewall and the second sidewall comprisinga first indentation and a second indentation, respectively, proximatethe posterior portion, wherein an intersection of the first sidewall andthe superior surface comprises a first chamfered edge and wherein anintersection of the second sidewall and the inferior surface comprises asecond chamfered edge. The insertion tool having a gripper extendingdistally from the handle, the gripper having a first fork and a secondfork extending generally parallel to the first fork, wherein a gap isprovided between the first fork and the second fork, the gap being sizedto allow the first fork to be inserted into the first indentation andthe second fork into the second indention. The insertion tool isremovably attachable to the implant and adapted to insert the implantbetween adjacent vertebrae in a first orientation with the first andsecond sidewalls configured to contact the adjacent vertebrae androtating the implant 90° to a second orientation with the superior andinferior surfaces configured to contact the adjacent vertebrae.

According to yet another embodiment, a system comprises an implant andan insertion tool. The implant having an elongate body having a centrallongitudinal axis extending through the body; an anterior portion and aposterior portion, the posterior portion having an internally threadedopening; a superior surface extending between the anterior portion andthe posterior portion; an inferior surface extending between theanterior portion and the posterior portion; a first sidewall extendingbetween the superior surface and the inferior surface on a first side ofthe longitudinal axis; and a second sidewall extending between thesuperior surface and the inferior surface on a second side of thelongitudinal axis, the first sidewall and the second sidewall comprisinga first indentation and a second indentation, respectively, proximatethe posterior portion, wherein the first indentation includes a superiorsidewall surface, an inferior sidewall surface, and a side surfaceextending between and connecting the respective superior sidewallsurface and the inferior sidewall surface, the superior sidewall surfaceand the side surface being connected with a first curved portion and theside surface and the inferior sidewall surface being connected with asecond curved portion, wherein the first indentation terminates at acurved wall such that the wall connects the superior sidewall surfaceand the inferior side wall surface with a semi-circular configuration,wherein an intersection of the first sidewall and the superior surfacecomprises a first chamfered edge and wherein an intersection of thesecond sidewall and the inferior surface comprises a second chamferededge. The insertion tool having a gripper extending distally from thehandle, the gripper having a first fork having a curved portionconfigured to mate with the curved wall of the first indentation. Theinsertion tool is removably attachable to the implant and adapted toinsert the implant between adjacent vertebrae in a first orientationwith the first and second sidewalls configured to contact the adjacentvertebrae and rotating the implant 90° to a second orientation with thesuperior and inferior surfaces configured to contact the adjacentvertebrae.

BRIEF DESCRIPTION OF THE DRAWINGS

Other aspects, features, and advantages of the present invention willbecome more fully apparent from the following detailed description, theappended claims, and the accompanying drawings in which like referencenumerals identify similar or identical elements.

FIG. 1 is a front view of a spacer according to a first exemplaryembodiment;

FIG. 2 is a top elevational view of the spacer shown in FIG. 1;

FIG. 3 is a top perspective view of the spacer shown in FIG. 1 attachedto an exemplary insertion tool;

FIG. 3A is a bottom perspective view of the spacer shown in FIG. 1attached to the insertion tool shown in FIG. 3;

FIG. 4 is a side elevational view of the spacer shown in FIG. 1 beinginserted into an intervertebral space prior to rotating;

FIG. 5 is a side elevational view of the spacer shown in FIG. 1 beinginserted into an intervertebral space after rotating;

FIG. 6 is a perspective view of a spacer according to a second exemplaryembodiment;

FIG. 7 is a front elevational view of the spacer shown in FIG. 6;

FIG. 8 is a side elevational view of the spacer shown in FIG. 6

FIG. 9 is a top plan view of the spacer shown in FIG. 6;

FIG. 10 is a front view of a spacer according to a third exemplaryembodiment;

FIG. 11 is a top view of the spacer shown in FIG. 10;

FIG. 12 is a series of three side views of spacer designs havingdifferent degrees of lordosis;

FIG. 13 is a back view of the spacer shown in FIG. 10 as intended to befirst positioned in the disc space;

FIG. 14 is a back view of the spacer as shown in FIG. 13 after beingrotated 90° and into final position in the disc space;

FIG. 15 is an inserter that may be used to install the spacer shown inFIG. 10; and

FIG. 16 is a close-up view of the inserter connected to the back end ofthe spacer.

DETAILED DESCRIPTION

In the drawings, like numerals indicate like elements throughout.Certain terminology is used herein for convenience only and is not to betaken as a limitation on the present invention. The terminology includesthe words specifically mentioned, derivatives thereof and words ofsimilar import. The embodiments illustrated below are not intended to beexhaustive or to limit the invention to the precise form disclosed.These embodiments are chosen and described to best explain the principleof the invention and its application and practical use and to enableothers skilled in the art to best utilize the invention.

Reference herein to “one embodiment” or “an embodiment” means that aparticular feature, structure, or characteristic described in connectionwith the embodiment can be included in at least one embodiment of theinvention. The appearances of the phrase “in one embodiment” in variousplaces in the specification are not necessarily all referring to thesame embodiment, nor are separate or alternative embodiments necessarilymutually exclusive of other embodiments. The same applies to the term“implementation.”

As used in this application, the word “exemplary” is used herein to meanserving as an example, instance, or illustration. Any aspect or designdescribed herein as “exemplary” is not necessarily to be construed aspreferred or advantageous over other aspects or designs. Rather, use ofthe word exemplary is intended to present concepts in a concretefashion.

Additionally, the term “or” is intended to mean an inclusive “or” ratherthan an exclusive “or”. That is, unless specified otherwise, or clearfrom context, “X employs A or B” is intended to mean any of the naturalinclusive permutations. That is, if X employs A; X employs B; or Xemploys both A and B, then “X employs A or B” is satisfied under any ofthe foregoing instances. In addition, the articles “a” and “an” as usedin this application and the appended claims should generally beconstrued to mean “one or more” unless specified otherwise or clear fromcontext to be directed to a singular form.

The use of figure numbers and/or figure reference labels in the claimsis intended to identify one or more possible embodiments of the claimedsubject matter in order to facilitate the interpretation of the claims.Such use is not to be construed as necessarily limiting the scope ofthose claims to the embodiments shown in the corresponding figures.

It should be understood that the steps of the exemplary methods setforth herein are not necessarily required to be performed in the orderdescribed, and the order of the steps of such methods should beunderstood to be merely exemplary. Likewise, additional steps may beincluded in such methods, and certain steps may be omitted or combined,in methods consistent with various embodiments of the present invention.

Although the elements in the following method claims, if any, arerecited in a particular sequence with corresponding labeling, unless theclaim recitations otherwise imply a particular sequence for implementingsome or all of those elements, those elements are not necessarilyintended to be limited to being implemented in that particular sequence.

The present disclosure provides embodiments of spinal implants that canbe inserted into a disc space sideways and rotated 90 degrees in situwithout overly distracting the disc space.

According to one embodiment, as shown in FIGS. 1-3A, an implant in theform of a spacer 100 is shown. As shown in FIGS. 4 and 5, spacer 100 isinserted into an intervertebral space 54 between a superior vertebralmember 50 and an inferior vertebral member 52. Spacer 100 can be formedfrom biocompatible materials, such as, but not limited to,polyetheretherketone (PEEK), titanium, titanium alloys, other surgicalgrade metals, alloys, or a combination thereof.

Referring back to FIGS. 1 and 2, spacer 100 includes an elongate body102 having a central longitudinal axis 104 extending through body 102.Optionally, body 102 includes a graft window or through-space 106extending generally centrally therethrough. Through-space 106 may beprovided to allow for the insertion of graft material (not shown) and/orto allow for the ingrowth of bone from either or both of vertebralmembers 50, 52.

Body 102 includes an anterior portion 110 that has an anterior end 112tapering toward longitudinal axis 104. Anterior portion 110 has amaximum width W1 that is orthogonal to longitudinal axis 104. Anteriorend 112 includes a first side wall 113 that extends obliquely towardlongitudinal axis 104 and a second side wall 114 that extends obliquelytoward longitudinal axis 104. Additionally, anterior end 112 alsoincludes a superior surface 115 that extends obliquely towardlongitudinal axis 104 and an inferior surface 116 that extends towardlongitudinal axis 104.

The convergence of walls 113, 114 and surfaces 115, 116 forms a blunttip 117 that enhances the ability of the implanting surgeon to inserttip 117 into intervertebral space 54 to maneuver the spacer 100 into adesired position. Further, all of walls 113, 114 and surfaces 115, 116are generally smooth and free of any teeth, ribs, or ridges so as not toscrape endplates 51, 53 of superior vertebral member 50 and inferiorvertebral member 52, respectively, during insertion of spacer 100 intointervertebral space 54. Additionally, all or some of walls 113, 114 andsurfaces 115, 116 can be generally flat or convex in shape with roundededges.

Optionally, superior surface 115 and inferior surface 116 can includeopenings 118, 119, respectively, formed therein. Openings 118, 119 canbe separate openings or opposing sides of a single opening that passesthrough anterior end 112. Openings 118, 119 can be used for the optionalinsertion of a radiopaque marker (not shown), if desired.

A posterior portion 120 is located distal from anterior portion 110.Posterior portion 120 includes a generally straight side 122.Optionally, a through-opening 124 extends through posterior end 120.Opening 124 can be used for the optional insertion of a radiopaquemarker (not shown), if desired.

Posterior end 120 has a minimum width W2 that is orthogonal tolongitudinal axis 104 such that minimum width W2 is less than maximumwidth W1. Body 102 can taper from maximum width W1 down to minimum widthW2 from anterior portion 110 to posterior portion 120. Thus, width W2may be generally smaller than width W1. In the alternative, width W2 maybe substantially the same as width W1 or width W2 may be larger thanwidth W1.

A superior surface 130 extends between tapered end 112 and posterior end120. Similarly, an inferior surface 140 also extends between anteriorend 112 and posterior end 120. Each of superior surface 130 and inferiorsurface 140 may be generally planar. In the alternative, the superiorand inferior surfaces 130, 140 may be curved or tapered to align withthe natural anatomy of the adjacent vertebral members 50, 52. Thesuperior and inferior surfaces 130, 140 may each include a plurality oflateral teeth 131 at posterior portion 120 and a portion of anteriorportion 110, although tapered anterior end 112 may form a nose portionsubstantially free of teeth 131. Teeth 131 are used to grip inferiorendplate 51 on superior vertebral member 50 and superior endplate 53 oninferior vertebral member 52.

A first sidewall 150 extends between superior surface 130 and inferiorsurface 140 on a first side 152 of longitudinal axis 104 and, similarly,a second sidewall 160 extends between superior surface 130 and inferiorsurface 140 on a second side 162 of longitudinal axis 104. The teeth 131on the superior and inferior surfaces 130, 140 may extend at least alonga portion between the first and second sidewalls 150, 160, except whereinterrupted by the through-space 106 and where chamfered to avoidscraping during rotation. Each sidewall 150, 160 can be slightly convexin shape or substantially planar in shape, for example. In oneembodiment each sidewall 150, 160 extends at an angle at least slightlyoblique relative to longitudinal axis 104, which results in posteriorwidth W2 being less than anterior width W1 so that, as spacer 100 isrotated between vertebral members 50, 52, only the portion of spacer 100proximate to width W1 engages and scrapes endplates 51, 53 duringrotation.

Additionally, sidewalls 150, 160 are generally smooth, without teeth, sothat spacer 100 can easily slide along inferior vertebral member 52 andsuperior vertebral member 50, respectively, during insertion of spacer100 into intervertebral space 54.

As shown in FIG. 1, the superior surface 130 comprises a first chamferededge 180 and the inferior surface 140 comprises a second chamfered edge190. For example, an intersection of first sidewall 150 and superiorsurface 130 may include first chamfered edge 180, and an intersection ofsecond sidewall 160 and inferior surface 140 may include a secondchamfered edge 190. The chamfered edges 180, 190 may interrupt the teeth131 on the superior and inferior surfaces 130, 140 at diagonal cornersrelative to one another in order to reduce the maximum distancetherebetween. Chamfered edges 180, 190 may each extend the length ofbody 102 between anterior end 112 to posterior portion 120. In thealternative, chamfered edges 18, 190 may extend along a portion of thelength of the body 102 between the anterior end 112 and the posteriorportion 120.

First and second chamfered edges 180, 190 may be substantially planar(i.e., beveled) or may have other configurations. For example, the firstchamfered edge 180 may include a first arcuate portion 182 having aradius R1, a linear portion 184 attached to first arcuate portion 182,and a second arcuate portion 186 attached to linear portion 184, distalfrom first arcuate portion 182. Second arcuate portion 186 has a radiusR2, which may or may not be the same as radius R1.

Across a first diagonal distance D1 from first chamfered edge 180,inferior surface 140 comprises second chamfered edge 190. Secondchamfered edge 190 may be substantially planar (i.e., beveled) or mayhave other configurations. For example, the second chamfered edge 190may include a first arcuate portion 192 having a radius R1, a linearportion 194 attached to first arcuate portion 190, and a second arcuateportion 196 attached to linear portion 194, distal from first arcuateportion 192. Second arcuate portion 196 has a radius R2, which may ormay not be the same as radius R1. The distance D1 between the firstchamfered edge 190 and the second chamfered edge 190 is minimized, whichpreferably lessens contact of the spacer 100 when rotated into positionin the vertebral disc space.

While chamfered edges 180, 190 are shown to form edges that provide areduced diagonal, those skilled in the art will recognize that edges180, 190 can be formed in other manners, such as, for example, bybeveling or filleting, such that first diagonal distance D1 is reducedfrom a diagonal formed with non-chamfered, non-beveled, or non-filletedopposing edges.

At least some of the plurality of laterally extending teeth 131 on bothsuperior surface 130 and inferior surface 140 may end prior to chamferededges 180, 190 to reduce the risk of scraping endplates 51, 53 ofsuperior vertebral member 50 and inferior vertebral member 52,respectively, during insertion of spacer 100 into intervertebral space54 and subsequent rotation. As shown in FIG. 2, teeth 131 taper inwardlytoward longitudinal axis 104 to further ameliorate scraping risk. Thedegree of taper or chamfer 180, 190 may be greatest at anterior portion110 and the degree of taper or chamfer 180, 190 may lessen towardsposterior end 120. In addition, the volume of chamfer 180, 190 may belargest for the first tooth at the anterior portion 110 and reduce involume towards the posterior end 120. In other words, the greatestdegree of chamfer 180, 190 may occur proximate to the anterior portion110.

An intersection of first sidewall 150 and inferior surface 140 forms acorner 142 and an intersection of second sidewall 160 and superiorsurface 120 forms a corner 132. Optionally, each of corners 142, 132 canalso be tapered or rounded to reduce the risk of scraping endplates 51,53 for vertebral members 50, 52, respectively, during insertion ofspacer 100 into intervertebral space 54. These corners 132, 142 may alsoextend substantially along the length of the spacer 100. A seconddiagonal distance between corners 142, 132 is shown in FIG. 1 asdiagonal D2 such that first diagonal distance D1 is at least less than asecond diagonal distance D2. Thus, the distance D1 is preferably smallerthan the distance D2 to reduce scraping of the endplates duringrotation.

With first diagonal distance D1 being less than second diagonal distanceD2, spacer 100 can be rotated in a direction indicated by curved arrow Ain FIG. 1 (clockwise as shown in FIG. 1) during insertion of spacer 100into intervertebral space 54, which results in less distraction ofvertebral members 50, 52 than if spacer 100 were to be rotated in adirection opposite arrow A (counter-clockwise as shown in FIG. 1).

Each of first sidewall 150 and second sidewall 160 comprises alongitudinal indentation 153, 163, respectively. Indentations 153, 163may be generally concave recesses cut into the sidewalls 150, 160 of thespacer 100. Instead of being arcuate, these concave recesses may havegenerally flat and angular sections. For example, indentation 153 may besegmented with generally planar sidewalls including a superior sidewallsurface 154, an inferior sidewall surface 156, and a side surface 158extending between and connecting the respective superior sidewallsurface 154 and the respective inferior sidewall surface 156. Thesuperior sidewall surface 154 may connect to side surface 158 via afirst generally obtuse angle (e.g., an angle greater than 90°).Similarly, the inferior sidewall surface 156 may connect to side surface158 via a second generally obtuse angle (e.g., an angle greater than90°). Although obtuse angles are shown, it is contemplated that thesidewall surfaces 154, 156 may connect with the side surface 158 atright angles or acute angles. Optionally, as shown in FIG. 1, each ofsuperior sidewall surface 154 and inferior sidewall surface 156 extendsat an oblique angle relative to a central horizontal plane P1 (extendingnormally out of the plane of the paper of FIG. 1), forming a taperedindentation 153.

Similarly, indentation 163 is segmented with generally planar sidewallsincluding a superior sidewall surface 164, an inferior sidewall surface166, and a side surface 168 extending between and connecting therespective superior sidewall surface 164 and the respective inferiorsidewall surface 166. Similar to indentation 153, the superior sidewallsurface 164 may connect to side surface 168 via a first generally obtuseangle (e.g., an angle greater than 90°). Similarly, the inferiorsidewall surface 166 may connect to side surface 168 via a secondgenerally obtuse angle (e.g., an angle greater than 90°). Althoughobtuse angles are shown, it is contemplated that the sidewall surfaces164, 166 may connect with the side surface 168 at right angles or acuteangles. In addition, each of superior sidewall surface 164 and inferiorsidewall surface 166 may extend at an oblique angle relative to centralhorizontal plane P1 (extending normally out of the plane of the paper ofFIG. 1), forming a tapered indentation 163.

Indentations 153, 163 are provided to support an insertion tool 200(shown in FIGS. 3-5) that is removably attachable to spacer 100 and isadapted to insert spacer 100 between adjacent vertebral members 50, 52.Insertion tool 200 includes a handle 210 and a gripper 220 extendingdistally from handle 210.

Gripper 220 has a first fork 222 and a second fork 224 extendinggenerally parallel to first fork 222, such that a gap is providedbetween first fork 222 and second fork 224. The gap is sized to allowfirst fork 222 to be inserted along longitudinal indentation 153 infirst sidewall 150 of spacer 100 and to allow second fork 224 to beinserted along longitudinal indention 163 in second sidewall 160.Optionally, forks 222, 224 can have a tapered cross-section that mateswith the tapered cross-section of indentations 153, 163, respectively.Alternatively, forks 222, 224 can have a different cross-section, aslong as forks 222, 224 can securely grip spacer 100 for insertion intointervertebral space 54.

Optionally, first fork 222 is biased toward second fork 224 so thatgripper 220 securely grips spacer 100 during the insertion process.Additionally, when insertion tool 200 is attached to spacer 100,insertion tool 200 is adapted to insert spacer 100 between adjacentvertebral members 50, 52 and to rotate spacer 100 about ninety degreesabout longitudinal axis 104 of spacer 100 from the position shown inFIG. 4 to the position shown in FIG. 5.

First and second forks 222, 224 may be positioned in respectivelongitudinal indentations 153, 163 such that the forks 222, 224 span alongitudinal distance along the indentations 153, 163. For example, thefirst and second forks 222, 224 may span more than half way, but lessthan the entire length of the implant 100. The forks 222, 224 may besized and configured such that the opposite side surfaces of therespective forks 222, 224 contact and engage the superior sidewallsurfaces 154, 164 and inferior sidewall surfaces 156, 166 of therespective indentations 153, 163. Similarly, a bottom surface of eachrespective fork 222, 224 mates with and contacts the side surfaces 158,168 of the indentations 153, 163. In this manner, the forks 222, 224 maybe respectively received in the indentations 153, 163 such that theforks do not form an outer surface of the spacer 100 and do notnecessarily contact the vertebral endplates during insertion or rotationof the spacer 100. Thus, the forks 222, 224 do not cam open or otherincrease the distance of the intervertebral disc space during insertionor rotation of the spacer 100 into its final position. Optionally, eachof first fork 222 and second fork 224 is laterally disposed within therespective longitudinal indentation 153, 163 so that, as spacer 100 isbeing rotated from the position shown in FIG. 4 to the position shown inFIG. 5, neither fork 222, 224 inadvertently scrapes either vertebralmember 50, 52 (i.e., spacer sidewalls 150, 160 extend laterallyoutwardly of forks 222, 224 so that sidewall 150, 160, and not forks222, 224, engage vertebral members 50, 52).

To implant spacer 100 into intervertebral space 54, spacer 100 isremovably attached to tool 200 as shown in FIGS. 3 and 4. First fork 222is slid into indentation 153 and second fork 224 is slid intoindentation 163 from posterior portion 120. Spacer 100 is then insertedinto intervertebral space 54 in the direction of arrow “B”, as shown inFIG. 4. The taper of anterior end 112 allows the inserting physician togenerally locate spacer 100 in intervertebral space 54 and to advancespacer 100 anteriorly in vertebral space 54. The smooth sidewalls 150,160 allow spacer 100 to slide along endplates 51, 53 of superiorvertebral members 50, 52, respectively, with minimal friction.

When spacer 100 is located in a desired position, tool 200 is rotated 90degrees, thereby rotating spacer 100 90 degrees as well, in thedirection of arrow “A” in FIG. 1, to the position shown in FIG. 5.Chamfered edges 180, 190 reduce distraction between vertebral members50, 42 as spacer 100 is rotated. Teeth 131 on superior surface 130 andinferior surface 140 grip endplates 51, 53, respectively, to reducepotential movement of spacer 100 between intervertebral members 50, 52.

An alternative embodiment of an implant, or spacer, 300 (“spacer 300”)is shown in FIGS. 6-9. Elements in spacer 300 that are identical toelements in spacer 100 are given the same reference numbers as thoseused for spacer 100. Spacer 300 is similar to spacer 100 except that, inaddition to first and second diametrically opposed chamfered edges 180,190, spacer 300 also includes a third chamfered edge 380 formed oninferior surface 340 (e.g., at an intersection of a first sidewall 350and an inferior surface 340) as well as a fourth chamfered edge 390 onthe diagonal opposite of the superior surface 330 (e.g., at anintersection of a second sidewall 360 and a superior surface 330). Thefour chamfered edges 180, 380, 190, 390 result in generally equal lengthdiagonals, thereby allowing for spacer 300 to be rotated eitherclockwise or counterclockwise about a longitudinal axis 304 withoutoverly distracting adjacent vertebral members 50, 52 and/or causingscraping of the vertebral members 50, 52. In this embodiment, due to thepresence of four chamfered edges 180, 190, 380, 390 the area of eachrespective chamfer 180, 190, 380, 390 may be less than in the embodimentshown in FIGS. 1-2 with only two diagonal chamfers 180, 190 in order tomaximize the contact area of the superior and inferior surfaces 330, 340with the vertebral endplates 50, 52.

Chamfered edges 180, 190, 380, 390 may extend along spacer 300 betweenanterior portion 310 and posterior portion 320 or a portion thereof.Teeth 331 on each of superior surface 330 and inferior surface 340 mayextend at least along a portion of spacer 300 between the first andsecond sidewalls 350, 360, except where interrupted by the through-space306 and where chamfered at chamfered edges 180, 190, 380, 390 to avoidscraping during rotation. The degree of taper or chamfer 180, 190, 380,390 may be greatest at anterior portion 310 and the degree of taper orchamfer 180, 190, 380, 390 may lessen towards posterior end 320. Inaddition, the volume of chamfer 180, 190, 380, 390 may be largest forthe first tooth at the anterior portion 310 and reduce in volume towardsthe posterior end 320. In other words, the greatest degree of chamfer180, 190, 380, 390 may occur proximate to the anterior portion 310.

Also, optionally, as shown in FIG. 8, superior surface 330 extends in afirst plane P2 extending perpendicularly from the plane of the paper ofFIG. 8 and inferior surface 340 extends in a second plane P3, extendingperpendicularly from the plane of the paper of FIG. 8, oblique to thefirst plane P2 to conform with natural spacing between adjacentvertebral members 50, 52. It will be appreciate that these planes P2, P3may be generally parallel, may be curved, or may increase in heighttoward the posterior end 320 if desired.

Further, anterior portion 310 has a widest portion having width W1 thatis orthogonal to longitudinal axis 304 and posterior portion 320 has anarrowest portion W2 that is orthogonal to longitudinal axis 304, withwidth W2 being smaller than with W1 so that, as spacer 300 is rotatedabout longitudinal axis 304 during insertion, only anterior portion 310needs to contact and distract intervertebral members 50, 52. Thoseskilled in the art however, will recognize that width W2 may be greaterthan or equal to width W1.

Additionally, as shown in FIGS. 6 and 9, side surface 158 may includeone or more graft holes 361 in fluid communication with through-space306. The graft holes 361 may extend from the side surface 158 to theopposite side surface 168 of the indentations 153, 163, respectively.The graft holes 361 may include three graft holes 361 central positionedalong the side surfaces 158, 168. As best seen in FIG. 8, the graftholes 361 may be generally elongate in dimension having a length greaterthan a width. The elongate graft holes 361 may be oriented such thatthey generally extend from the superior sidewall surface 154 to inferiorsidewall surface 156 of indentation 153 and from the superior side wallsurface 164 to the inferior sidewall surface 166 of indentation 163. Forexample, the elongate graft holes 361 may be oriented such that thelonger portion of the graft hole 361 is generally perpendicular to thelongitudinal axis of the body of the spacer 300. The graft holes 361 mayallow for interdigitation of the graft material (not shown) into thedisc space after spacer 300 is implanted.

An alternative embodiment of an implant, or spacer, 400 (“spacer 400”)is shown in FIGS. 10-14. Elements in spacer 400 that are identical toelements in spacer 100 are given the same reference numbers as thoseused for spacer 100. Spacer 400 is similar to spacer 100 except that theplurality of lateral teeth 131 are replaced with individual pyramidalteeth 431, the sidewalls 450, 460 are reconfigured, and there is adifferent connection mechanism with the insertion tool 500.

As best seen in FIG. 11, the superior and inferior surfaces 130, 140 ofthe spacer 400 include a plurality of teeth 431. The plurality of teeth431 include individual, discrete, spaced-apart teeth that may begenerally uniformly shaped and dimensioned. The teeth 431 may have agenerally pyramidal-shaped. The surface formed from the tip to the basefacing the first and second side walls 450, 460 may be generallyequidistant, and the surface from the tip to the base facing theanterior end 112 may be longer than the surface from the tip to the basefacing the posterior end 122. This configuration for the teeth 431 mayhelp the spacer 400 to resist expulsion and provide stability. Similarto teeth 131, portions of teeth 431 may be removed by chamfered edges180, 190, for example, to facilitate rotation of the spacer 400 in situ.These chamfered edges 180, 190 or bevels on opposite corners of thespacer 400 allow for easier rotation while also minimizingover-distraction. In this configuration, the implant 100 includes bevel180, 190 on opposite corners of the spacer's profile. The bevel cutsaway an otherwise sharp corner from the spacer 400, and allows forsmoother rotation in the disc space.

The sidewalls 450, 460 may include indentations 453, 463 proximate tothe posterior end 122 of the spacer 400. Each of the indentations 453,463 may be in the form of a recess extending a distance towards theanterior end 112. As best seen in FIG. 14, the indentation 453 may besegmented with a superior sidewall surface 454, an inferior sidewallsurface 456, and a side surface 458 extending between and connecting therespective superior sidewall surface 454 and the respective inferiorsidewall surface 456. The superior sidewall surface 454 and the sidesurface 458 may be connected with a first curved portion and the sidesurface 458 and the inferior sidewall surface 456 may be connected witha second curved portion. Similarly, indentation 463 may have the sameconfiguration for superior sidewall surface 464, inferior sidewallsurface 466, and side surface 468. As best seen in FIG. 12, theindentations 453, 463 may terminate at a wall 470 (indentation 453 isshown and indentation 463 is identical). Wall 470 may be curved suchthat it connects the superior sidewall surface 454, 464 and the inferiorside wall surface 456, 466 with a semi-circular configuration (e.g., ahalf circular arc). This semi-circular configuration may be configuredto receive and/or mate with a corresponding portion of an instrument(e.g., forks 222, 224 described in more detail below for instrument500).

Additionally, as shown in FIG. 12, sidewalls 450, 460 (sidewall 450 isshown and sidewall 460 is identical) may include one or more graft holes461 in fluid communication with through-space 106 extendingtherethrough. The graft holes 461 may extend from the sidewall 450 tothe opposite sidewall 460. The graft holes 461 may include a singlegraft hole 461 centrally positioned between the superior and inferiorsurfaces 130, 140. The graft hole 461 may be generally elongate indimension having a width greater than a height. The elongate graft hole461 may be oriented such that the longer portion of the graft hole 461is generally parallel to the longitudinal axis of the body of the spacer400. The graft hole 461 may also be generally aligned along alongitudinal axis with the indentations 453, 463.

FIG. 12 also shows three spacer configurations at 8 degrees, 15 degrees,and 22 degrees, respectively. The side views of spacer 400 show threedifferent degrees of lordosis, but it is envisioned that otherconfigurations (e.g., parallel, non-parallel, curved, tapered) betweenthe superior and inferior surfaces 130, 140 may be provided based on theclinical need.

Turning now to FIGS. 15 and 16, the spacer 400 may be connected to aninstrument 500, similar to instrument 200 described herein. Instead of asplayed connection feature, the first and second forks 222, 224 of thegripper 220 may be fixed tabs. For example, gripper 220 may includefirst fork 222 configured to engage and mate with the first indentation453 and second fork 224 configured to engage and mate with the secondindentation 463. In addition, instrument 500 may include a threadedconnector 502. Threaded connector 502 may have a plurality of outerthreads configured to engage a threaded connection point or internallythreaded opening 126 on the posterior face 122 of the implant 400. Thefirm connection between the instrument 500 and the spacer 400 allow theimplant to be inserted on its side (e.g., view in FIG. 13) and thenrotated into its final position (e.g., view in FIG. 14).

When implanting a traditional spinal interbody device in a disc spacewith lordosis, it is difficult to fit an implant with a height thatmatches the anterior height of the disk space, due to the substantiallysmaller posterior height of said disc space. Implant 400 is designedsuch that it can be initially implanted on its side and subsequentlyrotated 90° to its final position. This allows the spacer 400 to go intothe disc space initially with its width being considered its startingheight. Once in the disc space, the spacer 400 is rotatable to its finalposition, allowing the initially desired anterior height and lordosis.

It will be further understood that various changes in the details,materials, and arrangements of the parts which have been described andillustrated in order to explain the nature of this invention may be madeby those skilled in the art without departing from the scope of theinvention as expressed in the following claims.

What is claimed is:
 1. A system comprising: an implant having anelongate body having: a central longitudinal axis extending through thebody; an anterior portion and a posterior portion, the posterior portionhaving an internally threaded opening; a superior surface extendingbetween the anterior portion and the posterior portion; an inferiorsurface extending between the anterior portion and the posteriorportion; a first sidewall extending between the superior surface and theinferior surface on a first side of the longitudinal axis; and a secondsidewall extending between the superior surface and the inferior surfaceon a second side of the longitudinal axis, the first sidewall and thesecond sidewall comprising a first indentation and a second indentation,respectively, proximate the posterior portion, wherein an intersectionof the first sidewall and the superior surface comprises a firstchamfered edge and wherein an intersection of the second sidewall andthe inferior surface comprises a second chamfered edge; and an insertiontool having: a gripper extending distally from the handle, the gripperhaving a first fork and a second fork extending generally parallel tothe first fork, wherein a gap is provided between the first fork and thesecond fork, the gap being sized to allow the first fork to be insertedinto the first indentation and the second fork into the secondindention, wherein the insertion tool is removably attachable to theimplant and adapted to insert the implant between adjacent vertebrae ina first orientation with the first and second sidewalls configured tocontact the adjacent vertebrae and rotating the implant 90° to a secondorientation with the superior and inferior surfaces configured tocontact the adjacent vertebrae.
 2. The system of claim 1, wherein thesuperior surface and the inferior surface comprise a plurality of teeth.3. The system of claim 2, wherein the plurality of teeth comprisesdiscrete pyramidal teeth.
 4. The system of claim 3, wherein one of thepyramidal teeth has a first surface formed from a tip to a base of thepyramid facing the first sidewall and a second surface formed from thetip to the base of the pyramid facing the second sidewall, the first andsecond surfaces being generally equidistant.
 5. The system of claim 4,wherein a third surface from the tip to the base facing the anteriorportion being longer than a fourth surface from the tip to the basefacing the posterior portion of the implant.
 6. The system of claim 1,wherein the first indentation includes a superior sidewall surface, aninferior sidewall surface, and a side surface extending between andconnecting the respective superior sidewall surface and the inferiorsidewall surface, the superior sidewall surface and the side surfacebeing connected with a first curved portion and the side surface and theinferior sidewall surface being connected with a second curved portion.7. The system of claim 6, wherein the first indentation terminates at acurved wall such that the wall connects the superior sidewall surfaceand the inferior side wall surface with a semi-circular configuration.8. The system of claim 1, wherein the anterior portion comprises a firstside wall extending obliquely toward the longitudinal axis and a secondside wall extending obliquely toward the longitudinal axis.
 9. Thesystem of claim 1, wherein the anterior portion include a nose free ofteeth.
 10. The system of claim 1, wherein the body has an openingextending therethrough between the superior surface and the inferiorsurface.
 11. The system of claim 1, wherein the insertion tool furthercomprises a threaded connector having a plurality of outer threadsconfigured to engage the internally threaded opening in the posteriorportion of the implant.
 12. A system comprising: an implant having anelongate body having: a central longitudinal axis extending through thebody; an anterior portion and a posterior portion, the posterior portionhaving an internally threaded opening; a superior surface extendingbetween the anterior portion and the posterior portion; an inferiorsurface extending between the anterior portion and the posteriorportion; a first sidewall extending between the superior surface and theinferior surface on a first side of the longitudinal axis; and a secondsidewall extending between the superior surface and the inferior surfaceon a second side of the longitudinal axis, the first sidewall and thesecond sidewall comprising a first indentation and a second indentation,respectively, proximate the posterior portion, wherein the firstindentation includes a superior sidewall surface, an inferior sidewallsurface, and a side surface extending between and connecting therespective superior sidewall surface and the inferior sidewall surface,the superior sidewall surface and the side surface being connected witha first curved portion and the side surface and the inferior sidewallsurface being connected with a second curved portion, wherein the firstindentation terminates at a curved wall such that the wall connects thesuperior sidewall surface and the inferior side wall surface with asemi-circular configuration, wherein an intersection of the firstsidewall and the superior surface comprises a first chamfered edge andwherein an intersection of the second sidewall and the inferior surfacecomprises a second chamfered edge; and an insertion tool having: agripper extending distally from the handle, the gripper having a firstfork having a curved portion configured to mate with the curved wall ofthe first indentation, wherein the insertion tool is removablyattachable to the implant and adapted to insert the implant betweenadjacent vertebrae in a first orientation with the first and secondsidewalls configured to contact the adjacent vertebrae and rotating theimplant 90° to a second orientation with the superior and inferiorsurfaces configured to contact the adjacent vertebrae.
 13. The system ofclaim 12, wherein the superior surface and the inferior surface comprisea plurality of teeth.
 14. The system of claim 13, wherein the pluralityof teeth comprises discrete pyramidal teeth.
 15. The system of claim 14,wherein one of the pyramidal teeth has a first surface formed from a tipto a base of the pyramid facing the first sidewall and a second surfaceformed from the tip to the base of the pyramid facing the secondsidewall, the first and second surfaces being generally equidistant. 16.The system of claim 15, wherein a third surface from the tip to the basefacing the anterior portion being longer than a fourth surface from thetip to the base facing the posterior portion of the implant.
 17. Thesystem of claim 12, wherein the second indentation includes a superiorsidewall surface, an inferior sidewall surface, and a side surfaceextending between and connecting the respective superior sidewallsurface and the inferior sidewall surface, the superior sidewall surfaceand the side surface being connected with a first curved portion and theside surface and the inferior sidewall surface being connected with asecond curved portion.
 18. The system of claim 17, wherein the secondindentation terminates at a curved wall such that the wall connects thesuperior sidewall surface and the inferior side wall surface with asemi-circular configuration.
 19. The system of claim 18, wherein thegripper has a second fork having a curved portion configured to matewith the curved wall of the second indentation.
 20. The system of claim12, wherein the insertion tool further comprises a threaded connectorhaving a plurality of outer threads configured to engage the internallythreaded opening in the posterior portion of the implant.